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Headache After Diagnostic Lumbar Puncture (HELPUmeå)

Primary Purpose

Post-Lumbar Puncture Headache

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sprotte 25G needle, stylet reinserted
Sprotte 25G needle, stylet not reinserted
Sprotte 22G needle, stylet reinserted
Sprotte 22G needle, stylet not reinserted
Spinocan 25G needle, stylet reinserted
Spinocan 25G needle, stylet not reinserted
Sponsored by
Jonatan Salzer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-Lumbar Puncture Headache focused on measuring Lumbar puncture, Headache

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects undergoing diagnostic LP during their neurological work-up at Umeå University Hospital, Sweden, from 28 May 2013 until the study is fully recruited and;
  • Willing to participate and
  • Providing informed consent

Exclusion Criteria:

-Subjects unable to participate in the study follow-up

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Sprotte 25G needle, stylet reinserted

    Sprotte 25G needle, stylet not reinserted

    Sprotte 22G needle, stylet reinserted

    Sprotte 22G needle, stylet not reinserted

    Spinocan 25G needle, stylet reinserted

    Spinocan 25G needle, stylet not reinserted

    Arm Description

    Outcomes

    Primary Outcome Measures

    Odds ratio for post-lumbar puncture headache (any)
    Any post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).

    Secondary Outcome Measures

    Odds ratio for post-lumbar puncture headache (severe)
    Severe (preventing daily activities) post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).
    Headache duration (days)
    Proportion using analgesia
    Proportion on sick leave
    Proportion with back pain
    Proportion with radiating leg pain
    Multiplicative interactions between age (years), sex, BMI and needle visavi the outcome "any post-LP headache" in a multivariable logistic regression model
    Interactions between important predictors of headache and needle allocation, assessed in multivariable logistic regression models with interaction terms which are the products of the two potentially interacting variables. Age and BMI will be treated as continuous variables, sex and needle allocation as categorical variables.

    Full Information

    First Posted
    May 2, 2019
    Last Updated
    May 20, 2019
    Sponsor
    Jonatan Salzer
    Collaborators
    Umeå University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03960749
    Brief Title
    Headache After Diagnostic Lumbar Puncture
    Acronym
    HELPUmeå
    Official Title
    The Importance of Needle Size, Needle Design and Stylet Reinsertion to Prevent Post-lumbar Puncture Headache, a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    May 28, 2013 (Actual)
    Primary Completion Date
    June 24, 2018 (Actual)
    Study Completion Date
    October 11, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Jonatan Salzer
    Collaborators
    Umeå University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objectives of this study are to investigate the effects of needle design, needle size and stylet reinsertion on the risk for headache after diagnostic LP (lumbar puncture, Post-LP headache). The following needles are used in the study: Sprotte 25 Gauge (G) (0.5 mm) atraumatic needle with introducer Sprotte 22 G (0.7 mm) atraumatic needle with introducer Spinocan 25 G (0.5 mm) cutting needle

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-Lumbar Puncture Headache
    Keywords
    Lumbar puncture, Headache

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized, parallel group. Randomization between three different lumbar puncture needles and between stylet reinsertion of not before needle withdrawal.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    The participants are not informed about the allocated needle. The follow-up telephone calls (outcome assessment) are made by an assistant nurse who is unaware of randomization allocation.
    Allocation
    Randomized
    Enrollment
    1000 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Sprotte 25G needle, stylet reinserted
    Arm Type
    Experimental
    Arm Title
    Sprotte 25G needle, stylet not reinserted
    Arm Type
    Experimental
    Arm Title
    Sprotte 22G needle, stylet reinserted
    Arm Type
    Experimental
    Arm Title
    Sprotte 22G needle, stylet not reinserted
    Arm Type
    Experimental
    Arm Title
    Spinocan 25G needle, stylet reinserted
    Arm Type
    Experimental
    Arm Title
    Spinocan 25G needle, stylet not reinserted
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Sprotte 25G needle, stylet reinserted
    Intervention Description
    Lumbar puncture with small bore atraumatic needle, stylet reinserted before needle withdrawal
    Intervention Type
    Device
    Intervention Name(s)
    Sprotte 25G needle, stylet not reinserted
    Intervention Description
    Lumbar puncture with small bore atraumatic needle, stylet not reinserted before needle withdrawal
    Intervention Type
    Device
    Intervention Name(s)
    Sprotte 22G needle, stylet reinserted
    Intervention Description
    Lumbar puncture with larger bore atraumatic needle, stylet reinserted before needle withdrawal
    Intervention Type
    Device
    Intervention Name(s)
    Sprotte 22G needle, stylet not reinserted
    Intervention Description
    Lumbar puncture with larger bore atraumatic needle, stylet not reinserted before needle withdrawal
    Intervention Type
    Device
    Intervention Name(s)
    Spinocan 25G needle, stylet reinserted
    Intervention Description
    Lumbar puncture with small bore cutting needle, stylet reinserted before needle withdrawal
    Intervention Type
    Device
    Intervention Name(s)
    Spinocan 25G needle, stylet not reinserted
    Intervention Description
    Lumbar puncture with small bore cutting needle, stylet not reinserted before needle withdrawal
    Primary Outcome Measure Information:
    Title
    Odds ratio for post-lumbar puncture headache (any)
    Description
    Any post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).
    Time Frame
    Up to 14 days after LP
    Secondary Outcome Measure Information:
    Title
    Odds ratio for post-lumbar puncture headache (severe)
    Description
    Severe (preventing daily activities) post-lumbar puncture headache (as defined in the international classification of headache disorders 3 (ICHD-3).
    Time Frame
    Up to 14 days after LP
    Title
    Headache duration (days)
    Time Frame
    Until cessation, up to 14 days after LP
    Title
    Proportion using analgesia
    Time Frame
    During post-lumbar puncture headache, up to 14 days after LP
    Title
    Proportion on sick leave
    Time Frame
    During post-lumbar puncture headache, up to 14 days after LP
    Title
    Proportion with back pain
    Time Frame
    Up to 14 days after LP
    Title
    Proportion with radiating leg pain
    Time Frame
    Up to 14 days after LP
    Title
    Multiplicative interactions between age (years), sex, BMI and needle visavi the outcome "any post-LP headache" in a multivariable logistic regression model
    Description
    Interactions between important predictors of headache and needle allocation, assessed in multivariable logistic regression models with interaction terms which are the products of the two potentially interacting variables. Age and BMI will be treated as continuous variables, sex and needle allocation as categorical variables.
    Time Frame
    Up to 14 days after LP
    Other Pre-specified Outcome Measures:
    Title
    Procedure duration (minutes)
    Description
    Procedure duration from start of procedure (defined as when the operator starts palpating the iliac crest) until procedure cessation (defined as when the needle is withdrawn from the participant).
    Time Frame
    During the lumbar puncture
    Title
    Proportion undergoing needle switch
    Description
    Technical difficulties may differ between needles and thus the proportion undergoing needle switch due to these difficulties may differ.
    Time Frame
    During the lumbar puncture
    Title
    Opening pressure (cm H2O)
    Description
    Opening pressure measured immediately after cerebrospinal fluid (CSF) contact using a thin tube attached to a paper ruler, using the skin entry hole as reference point. This is only performed in the recumbent position.
    Time Frame
    During the lumbar puncture

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects undergoing diagnostic LP during their neurological work-up at Umeå University Hospital, Sweden, from 28 May 2013 until the study is fully recruited and; Willing to participate and Providing informed consent Exclusion Criteria: -Subjects unable to participate in the study follow-up

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    11061243
    Citation
    Evans RW, Armon C, Frohman EM, Goodin DS. Assessment: prevention of post-lumbar puncture headaches: report of the therapeutics and technology assessment subcommittee of the american academy of neurology. Neurology. 2000 Oct 10;55(7):909-14. doi: 10.1212/wnl.55.7.909. No abstract available.
    Results Reference
    background
    PubMed Identifier
    19009898
    Citation
    Hyllienmark L, Zachau AC. [Diagnostic lumbal puncture]. Lakartidningen. 2008 Oct 8-14;105(41):2844-9. No abstract available. Swedish.
    Results Reference
    background
    PubMed Identifier
    16116106
    Citation
    Armon C, Evans RW; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Addendum to assessment: Prevention of post-lumbar puncture headaches: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2005 Aug 23;65(4):510-2. doi: 10.1212/01.wnl.0000173034.96211.1b.
    Results Reference
    background
    PubMed Identifier
    9102578
    Citation
    Strupp M, Brandt T. Should one reinsert the stylet during lumbar puncture? N Engl J Med. 1997 Apr 17;336(16):1190. doi: 10.1056/NEJM199704173361616. No abstract available.
    Results Reference
    background
    PubMed Identifier
    21549395
    Citation
    Hammond ER, Wang Z, Bhulani N, McArthur JC, Levy M. Needle type and the risk of post-lumbar puncture headache in the outpatient neurology clinic. J Neurol Sci. 2011 Jul 15;306(1-2):24-8. doi: 10.1016/j.jns.2011.04.004. Epub 2011 May 5.
    Results Reference
    background
    PubMed Identifier
    11756618
    Citation
    Strupp M, Schueler O, Straube A, Von Stuckrad-Barre S, Brandt T. "Atraumatic" Sprotte needle reduces the incidence of post-lumbar puncture headaches. Neurology. 2001 Dec 26;57(12):2310-2. doi: 10.1212/wnl.57.12.2310.
    Results Reference
    background

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    Headache After Diagnostic Lumbar Puncture

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